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IAC Express 2009 |
| Issue number 819: August 24, 2009 |
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Please click here to subscribe to IAC Express
as well as other FREE IAC periodicals. |
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Contents
of this Issue
Select a title to jump to the article. |
- CDC
publishes ACIP recommendations for use of influenza A (H1N1) 2009
monovalent vaccine
- FDA
licenses new Hib vaccine, Hiberix
- It's time
to start vaccinating people against seasonal influenza!
- CDC
releases guidance for businesses and institutions of higher education
related to influenza prevention
- JAMA
publishes articles on HPV vaccine
- IAC
redesigns its Immunization Topics section
- IAC's
Video of the Week reports on preventing neonatal tetanus in Cote d'Ivoire
- "CDC
Features" includes information for parents and patients about meningitis
and pertussis
- IAC's
padded screening questionnaires for contraindications now have English on
front, Spanish on the back--a popular translation at no added cost!
- August
21 MMWR includes previously published article about oseltamivir-resistant
H1N1 virus infection in two immunosuppressed patients
- MMWR
publishes correction to table in the ACIP seasonal influenza
recommendations
- VIS
translations: VISs for influenza (TIV) and Td/Tdap vaccines now available
in Turkish
- National
Committee for Quality Assurance offers a free online continuing education
program
- World
Rabies Day Symposium scheduled for September 28 in Atlanta
-
Influenza Congress to be held November 18-20 in Washington, DC
-
Massachusetts Immunization Action Partnership's 14th annual conference set
for October 15
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| Abbreviations |
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AAFP, American Academy of Family Physicians; AAP,
American Academy of Pediatrics; ACIP, Advisory Committee on Immunization
Practices; AMA, American Medical Association; CDC, Centers for Disease
Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization
Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NCIRD,
National Center for Immunization and Respiratory Diseases; NIVS, National
Influenza Vaccine Summit; VIS, Vaccine Information Statement; VPD,
vaccine-preventable disease; WHO, World Health Organization. |
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Issue 819: August 24, 2009 |
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1. |
CDC publishes ACIP recommendations for use of influenza A (H1N1) 2009
monovalent vaccine
CDC published "Use of Influenza A (H1N1) 2009
Monovalent
Vaccine: Recommendations of the Advisory Committee on
Immunization Practices (ACIP), 2009" in an August 21 MMWR
Early Release. The summary follows in its entirety.
This report provides recommendations by CDC's Advisory
Committee on Immunization Practices (ACIP) regarding the use
of vaccine against infection with novel influenza A (H1N1)
virus. Information on vaccination for seasonal influenza has
been published previously (CDC. Prevention and control of
seasonal influenza with vaccines: recommendations of the
Advisory Committee on Immunization Practices [ACIP], 2009.
MMWR 2009;58[No. RR-8]). Vaccines against novel influenza A
(H1N1) virus infection have not yet been licensed; however,
licensed vaccine is expected to be available by mid-October
2009. On July 29, 2009, ACIP reviewed epidemiologic and
clinical data to determine which population groups should be
targeted initially for vaccination. ACIP also considered the
projected vaccine supply likely to be available when vaccine
is first available and the expected increase in vaccine
availability during the following 6 months. These
recommendations are intended to provide vaccination programs
and providers with information to assist in planning and to
alert providers and the public about target groups
comprising an estimated 159 million persons who are
recommended to be first to receive influenza A (H1N1) 2009
monovalent vaccine. The guiding principle of these
recommendations is to vaccinate as many persons as possible
as quickly as possible. Vaccination efforts should begin as
soon as vaccine is available. State and local health
officials and vaccination providers should make decisions
about vaccine administration and distribution in accordance
with state and local conditions. Highlights of these
recommendations include (1) the identification of five
initial target groups for vaccination efforts (pregnant
women, persons who live with or provide care for infants
aged <6 months, healthcare and emergency medical services
personnel, children and young adults aged 6 months-24 years,
and persons aged 25-64 years who have medical conditions
that put them at higher risk for influenza-related
complications), (2) establishment of priority for a subset
of persons within the initial target groups in the event
that initial vaccine availability is unable to meet demand,
and (3) guidance on use of vaccine in other adult population
groups as vaccine availability increases. Vaccination and
healthcare providers should be alert to announcements and
additional information from state and local health
departments and CDC concerning vaccination against novel
influenza A (H1N1) virus infection. Additional information
is available from state and local health departments and
from CDC's influenza website (http://www.cdc.gov/flu).
To access the complete recommendations in web-text (HTML)
format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm
To access a ready-to-print (PDF) version of this issue of
MMWR, go to:
http://www.cdc.gov/mmwr/pdf/rr/rr58e0821.pdf
To receive a FREE electronic subscription to MMWR (which
includes new ACIP recommendations), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html
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2. |
FDA licenses new Hib vaccine, Hiberix
On August 19, FDA issued a press release
announcing that it
had approved a new Hib vaccine, Hiberix. Hiberix is licensed
for active immunization for the prevention of invasive
disease caused by Haemophilus influenzae type b (Hib) when
administered as a booster dose in children 15 months through
4 years of age (prior to fifth birthday).
The press release is reprinted below in its entirety.
ACCELERATED APPROVAL OF HIBERIX TO HELP SUSTAIN ADEQUATE
VACCINE SUPPLY
Vaccine Approved as a Hib Booster Dose
The U.S. Food and Drug Administration today approved
Hiberix, a Haemophilus influenzae type b (Hib) vaccine, as a
booster dose for children 15 months through 4 years old.
Hiberix is manufactured by GlaxoSmithKline, with U.S.
headquarters in Research Triangle Park, NC, and
Philadelphia.
A nationwide shortage of Hib vaccine began in December 2007
due to a voluntary recall by the manufacturer and subsequent
production suspension of PedvaxHIB and COMVAX, two of four
vaccines licensed in the United States for primary and
booster immunization against invasive disease due to Hib.
Both PedvaxHIB and COMVAX vaccines are manufactured by Merck
& Co. Inc. (Whitehouse Station, NJ).
This shortage resulted in a recommendation by the U.S.
Centers for Disease Control and Prevention to temporarily
defer the Hib vaccine booster dose for children who were not
at high risk for infection, until the vaccine supply could
be restored. This deferral was in effect from Dec. 18, 2007,
through June 25, 2009.
Although current vaccine supply is sufficient to reinstate
the booster dose and begin catch-up vaccination, it is not
yet ample enough to support mass vaccination of all children
whose boosters were deferred.
"The FDA approved Hiberix under the agency's accelerated
approval pathway," said Karen Midthun, MD, acting director
of the FDA's Center for Biologics Evaluation and Research.
"This approval will provide an additional safe and effective
vaccine to help ensure that there is an adequate Hib vaccine
supply during necessary catch-up vaccinations."
Before the availability of Hib vaccines, Hib disease was the
leading cause of bacterial meningitis among children under 5
years old in the United States. Meningitis is an infection
of the tissue covering the brain and spinal cord, which can
lead to lasting brain damage and deafness. Hib disease can
also cause pneumonia, severe swelling in the throat,
infections of the blood, joints, bones, and tissue covering
of the heart, as well as death. Hib disease is spread
through the air by coughing and sneezing.
In 1992, the FDA disseminated rules regarding accelerated
approval. The rules allow for earlier approval of treatments
that have been studied for their safety and effectiveness in
treating serious or life-threatening illnesses and that
provide meaningful therapeutic benefit to patients over
existing treatments (including products that provide
prophylaxis to those who would not otherwise be treated
during a shortage). The use of such an approach can shorten
the time required for product testing prior to receiving FDA
approval. Accelerated approval is granted on the condition
that clinical trials are continued during the post-approval
marketing of the product to verify the anticipated clinical
benefit.
Hiberix is used in nearly 100 countries. The FDA based its
conclusion that Hiberix is safe and effective for use as a
booster dose in certain children in the United States on
data from seven clinical studies conducted in Europe, Latin
America, and Canada that involved more than 1,000 children.
As part of the approval, the manufacturer, GlaxoSmithKline,
will conduct a post-market study in the United States to
evaluate the safety and immunogenicity of primary and
booster vaccination with Hiberix compared to a Hib vaccine
already licensed in the United States. The study is intended
to confirm the clinical benefit of booster immunization with
Hiberix in accordance with the accelerated approval
regulations, and to provide additional data on Hiberix for
young infants.
The most common side effects seen in the studies following a
booster dose of Hiberix included pain and redness at the
injection site, fever, fussiness, loss of appetite, and
restlessness.
FDA's Recall Notice on PedvaxHIB and COMVAX:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm053289.htm
U.S. Centers for Disease Control and Prevention's "Hib
Vaccine--Q&A for Providers about the Return to the Hib
'Booster' Dose":
http://www.cdc.gov/vaccines/vpd-vac/hib/faqs-return-to-booster-hcp.htm
FDA's website on fast-track, accelerated approval and
priority review:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm
Federal Register, Dec. 11, 1992, Final Rule, Preamble, New
Drug, Antibiotic, and Biological Drug Product Regulations;
Accelerated Approval:
http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3627b2bm.pdf
To access the press release online, go to:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm179533.htm
To access the vaccine package insert, go to:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM179530.pdf
To access the approval letter, go to:
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm179531.htm
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3. |
It's time to start vaccinating people against seasonal influenza!
Many healthcare professionals have been asking if
it's too
soon to start vaccinating patients against seasonal
influenza. The answer is no--CDC advises to begin
administering seasonal influenza vaccine as soon as vaccine
becomes available.
Vaccinating now with seasonal influenza vaccine will allow
more time for healthcare providers to focus on later
immunization efforts when vaccine for 2009 H1N1 influenza A
virus becomes available. You will be vaccinating against
both seasonal influenza and 2009 H1N1 throughout the fall
and winter, so it's best to get a head start on your efforts
starting now.
In addition, early vaccination of children younger than age
9 years who are first time vaccinees (or who failed to get
their second dose in the preceding season) can be helpful in
assuring routine second doses before the influenza season
begins.
Finally, it's always a good rule of thumb to take advantage
of an opportunity to vaccinate instead of relying on
patients to come back for another appointment.
Many resources regarding influenza disease and vaccination
are available to healthcare professionals and the public.
Following is a list of some of them.
To access the National Influenza Vaccine Summit website, go
to:
http://www.preventinfluenza.org
To access IAC's Seasonal Influenza web section, go to:
http://www.immunize.org/influenza
To access IAC's H1N1 Influenza web section, go to:
http://www.immunize.org/h1n1
To access CDC's Seasonal Flu web section, go to:
http://www.cdc.gov/flu
To access CDC's Novel H1N1 Flu web section, go to:
http://www.cdc.gov/h1n1flu
To access IAC's print pieces related to influenza, including
screening questionnaires, patient education pieces, and
sample standing orders, go to:
http://www.immunize.org/printmaterials/dis_inf.asp
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4. |
CDC releases guidance for businesses and institutions of higher education
related to influenza prevention
CDC recently posted new or updated information to
various
sub-sections of its H1N1 Flu web section. Following are the
titles and URLs of documents that have been posted since the
August 17 issue of IAC Express:
CDC Guidance for Businesses and Employers To Plan and
Respond to the 2009-2010 Influenza Season
http://www.cdc.gov/h1n1flu/business/guidance
Preparing for the Flu: A Communication Toolkit for
Businesses and Employers
http://www.cdc.gov/h1n1flu/business/toolkit
CDC Guidance for Responses to Influenza for Institutions of
Higher Education during the 2009-2010 Academic Year
http://www.cdc.gov/h1n1flu/institutions/guidance
Technical Report on CDC Guidance for Responses to Influenza
for Institutions of Higher Education during the 2009-2010
Academic Year
http://www.cdc.gov/H1N1flu/institutions/guidance/technical.htm
Preparing for the Flu: A Communication Toolkit for
Institutions of Higher Education
http://www.cdc.gov/h1n1flu/institutions/toolkit
FOR MORE INFORMATION
The home page of CDC's H1N1 Flu web section can be accessed
from
http://www.cdc.gov/h1n1flu
IAC has gathered information related to H1N1 influenza into
a single web section at
http://www.immunize.org/h1n1
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5. |
JAMA publishes articles on HPV vaccine
On August 19, the Journal of the American Medical
Association (JAMA) published an article co-authored by CDC
and FDA that summarizes reports to the Vaccine Adverse Event
Reporting System (VAERS) related to HPV vaccine administered
from June 1, 2006, through December 31, 2008. This is the
first published postlicensure study that includes clinical
review of medical records associated with reports to VAERS.
To access the abstract for "Postlicensure Safety
Surveillance for Quadrivalent Human Papillomavirus
Recombinant Vaccine," go to:
http://jama.ama-assn.org/cgi/content/short/302/7/750?home
To read a FDA summary about HPV vaccine safety that includes
information from the new study, go to:
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm
The JAMA issue also includes an editorial that discusses the
risks and benefits of HPV vaccination and a special
communication that critiques the marketing of HPV vaccine.
Links to both are given below:
To access the full text of the editorial, "The Risks and
Benefits of HPV Vaccination," go to:
http://jama.ama-assn.org/cgi/content/full/302/7/795?home
To access the abstract for the special communication,
"Marketing HPV Vaccine: Implications for Adolescent Health
and Medical Professionalism," go to:
http://jama.ama-assn.org/cgi/content/short/302/7/781?home
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6. |
IAC redesigns its Immunization Topics section
On August 19, IAC announced the completion of
another phase
of its website redesign. The Immunization Topics section has
been completely redesigned and can be accessed at
http://www.immunize.org/iztopics
The topics covered in this section include international
adoption, dialysis, vaccination rate disparities,
vaccination of healthcare personnel, the hepatitis B birth
dose, vaccination in long-term care, vaccine mandates and
exemptions, vaccination for men who have sex with men,
needle safety, pregnancy, immunization registries, tattoos
and body piercing, and travel. Each page includes links to a
wide variety of relevant resources.
Be sure to check out this updated resource at
http://www.immunize.org/iztopics
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7. |
IAC's Video of the Week reports on preventing neonatal tetanus in Cote
d'Ivoire
IAC encourages IAC Express readers to watch a
2.5-minute
video on preventing neonatal tetanus in Cote D'Ivoire.
Tetanus is responsible for 7 percent of neonatal deaths
worldwide. The bacterium thrives in dirt and rust and can be
contracted by newborns through unsanitary conditions during
childbirth. To address this issue, the government of Cote
d'Ivoire, with the support of UNICEF and other international
partners, is offering free tetanus vaccinations to more than
5 million women.
The video will be available on the home page of IAC's
website through August 30. To access it, go to:
http://www.immunize.org and click on the image under the
words Video of the Week. It may take a few moments for the
video to begin playing; please be patient!
Remember to bookmark IAC's home page to view a new video
every Monday. To view an IAC Video of the Week from the
past, go to the video archive at
http://www.immunize.org/votw/jul09.asp
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8. |
"CDC
Features" includes information for parents and patients about meningitis and
pertussis
The "CDC Features" web section includes new
articles about
meningitis and pertussis targeted toward parents and
patients.
To access "Pertussis (Whooping Cough)--What You Need To
Know," go to:
http://www.cdc.gov/Features/Pertussis
To access "Have You Heard About How To Prevent Meningococcal
Disease?" go to http://www.cdc.gov/Features/CDCtv/Meningitis
To access an alphabetical index of all "CDC Features," go
to:
http://www.cdc.gov/az
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9. |
IAC's padded screening questionnaires for contraindications now have English on
front, Spanish on the back--a popular translation at no added cost!
In response to demand, IAC now has a
Spanish-language
translation of the questions on its padded Screening
Questionnaire for Child and Teen Immunization and Screening
Questionnaire for Adult Immunization. Printed on the back of
the English page, the Spanish page has been added to this
product at no additional cost.
The questionnaires give you and your patients a quick, easy,
and thorough way to determine if they have contraindications
and precautions to vaccination. Patients fill out the
questionnaire with yes-or-no answers while waiting to be
seen, allowing you to review their responses quickly and be
confident you're not missing any contraindications or
precautions.
The questionnaires come in convenient tear-off pads of 100
sheets. The price per pad is economical (discounts for two
pads or more), so you'll be able to keep pads at the
receptionist's desk, the nurse's station, and in every exam
room. Each pad comes with four English-language reference
sheets (printed on heavy-weight paper) for health
professionals.
Prices start at $16 each for one pad and drop to $12 each
for two, $11 each for three, and $10 each for four. For
quotes on larger quantities or customizing, call (651) 647-9009 or email
admininfo@immunize.org
To learn more about the padded screening questionnaires, or
to order online or download an order form, visit
Screening Questionnaire for Child and Teen Immunization
http://www.immunize.org/shop/pad_sqchild.asp
Screening Questionnaire for Adult Immunization
http://www.immunize.org/shop/pad_sqadult.asp
IAC's offers other products for sale, including educational
videos and personal immunization record cards, at
http://www.immunize.org/shop
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10. |
August 21 MMWR includes previously published article about oseltamivir-resistant
H1N1 virus infection in two immunosuppressed patients
CDC published "Oseltamivir-Resistant Novel
Influenza A
(H1N1) Virus Infection in Two Immunosuppressed Patients--Seattle, Washington, 2009" in the August 21 MMWR. This
report was previously released as an MMWR Dispatch on August
14, and was previously covered in IAC Express on August 17.
To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5832a3.htm
To access a ready-to-print (PDF) version of this issue of
MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5832.pdf
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11. |
MMWR publishes correction to table in the ACIP seasonal influenza
recommendations
CDC published "Errata: Vol. 58, No. RR-8" in the
August 21
MMWR. This article corrects information in Table 2 (page 13)
of ACIP's "Prevention and Control of Seasonal Influenza with
Vaccines," released on July 31.
To access the full article in web-text (HTML) format, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5832a4.htm
To access a ready-to-print (PDF) version of this issue of
MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5832.pdf
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12. |
VIS translations: VISs for influenza (TIV) and Td/Tdap vaccines now available
in Turkish
The current versions of the VISs for seasonal
injectable
influenza vaccine (dated 8/11/09) and for Td/Tdap vaccine
(dated 11/18/08) are now available on the IAC website in
Turkish. IAC gratefully acknowledges Mustafa Kozanoglu, MD,
and Murat Serbest, MD, for the translations.
To obtain the VIS for seasonal injectable influenza vaccine
(TIV) in Turkish, go to:
http://www.immunize.org/vis/tu_flu06.pdf
To obtain the VIS for seasonal injectable influenza vaccine
(TIV) in English, go to:
http://www.immunize.org/vis/2flu.pdf
To obtain the VIS for Td/Tdap vaccine in Turkish, go to:
http://www.immunize.org/vis/tu_td94.pdf
To obtain the VIS for Td/Tdap vaccine in English, go to:
http://www.immunize.org/vis/td_tdap.pdf
For information about the use of VISs, and for VISs in more
than 35 languages, visit IAC's VIS web section at
http://www.immunize.org/vis
For general information about VISs from CDC's website go to:
http://www.cdc.gov/vaccines/pubs/vis
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13. |
National Committee for Quality Assurance offers a free online continuing
education program
The National Committee for Quality Assurance is
offering a
free online continuing education program titled "Best
Practices in Childhood and Adolescent Immunization." The
program is intended for physicians, nurses, and pharmacists.
For more information, go to:
http://www.ncqa.org/tabid/82/default.aspx
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14. |
World Rabies Day Symposium scheduled for September 28 in Atlanta
The CDC World Rabies Day Symposium is scheduled
for
September 28 in Atlanta at the CDC Global Communications
Center. The program will focus on the importance of rabies
prevention and control at the global and national levels, as
well as human and animal rabies epidemiology, diagnosis, and
surveillance issues.
For more information, go to:
http://www.cdc.gov/rabies/events/WRD09.html
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15. |
Influenza Congress to be held November 18-20 in Washington, DC
"Influenza Congress USA" will bring together
global
pharmaceutical companies, biotechs, government
representatives, academicians, and investors to discuss
influenza policy and planning and research and development.
For more information, go to:
http://www.terrapinn.com/2009/usaflu/index.stm
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16. |
Massachusetts Immunization Action Partnership's 14th annual conference set
for October 15
The 14th annual Massachusetts Immunization Action
Partnership conference is scheduled for October 15 in
Marlborough, MA. The keynote speaker will be Dr. Ari Brown,
pediatrician and co-author of "Baby 411: Clear Answers and
Smart Advice for Your Baby's First Year" and "Toddler 411:
Clear Answers & Smart Advice for Your Toddler."
For more information, go to:
http://www.mass.gov/Eeohhs2/docs/dph/cdc/immunization/miap_brochure.pdf
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